Smoking, Smoking Cessation, Surgical Procedure, Unspecified
Conditions
Keywords
Smoking, Smoking Cessation, Tobacco Use Disorder, Surgery
Brief summary
The goal of this clinical trial is to assess efficacy of an intensive pre-surgical intervention to quit smoking in smoking patients who will be operated on implant orthopedic surgery or general and urological surgery. The main question\[s\] it aims to answer are: * Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to a brief intervention * Evaluate the implementation of this protocol. Participants will be randomized to 2 intervention groups (patients programmed for protesic implant orthopedic surgery in the first group, and general and urological surgery) and 2 control groups (stratified in the same manner as the intervention groups), and will be monitored through telematic check ups via phone calls.
Detailed description
1. Subject recruitment in pre surgical anesthesiology consults, data collection and randomization within 48 hours of said visit. 2. Subjects in the intensive intervention group will be sent to a specialized Preventive Medicine consult for smoking cessation, completing 6 visits (2 before surgical intervention, 4 visits withint the following 12 months). Subjects in the control group will receive brief advice on quitting smoking through a phone call the the same day randomization is performed. Both groups will receive follow up calls at months 1, 3, 6, and 12, after surgical intervetion. All patients will have their smoking habits evaluated and the relevant data about the surgical intervention collected the day of the intervention. 3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are necessary. 4. Data entry and quality control of the database will be performed periodically for the duration of the study.
Interventions
BEHAVIORALIntensive intervention for smoking cessation
Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.
BEHAVIORALBrief intervention for smoking cessation
Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open, controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must 18 years old or older, and be able to consent. * Surgery programmed for at least 4 weeks after inclusion in the study. * Smokers
Exclusion criteria
* Pregnancy * Already under treatment for smoking cessation * Inability to consent due to cognitive impairment or language barrier. * Non-primary knee or hip replacement surgery * Participation in any study that forbids use of nicotine substitution therapy (dermal, oral)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco use | Evaluated at 1, 3, 6, and 12 months after surgical intervention | Change in self reported tobacco use (smoking) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in rate of different type of tobbaco product users | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Cigarettes, cigars, rolling tobacco, etc. |
| Changes in tobacco use pattern | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Amount and frequency (daily, weekly, sporadically) |
| Changes in degree of nicotine dependency | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Fagerström test \[low dependency (0-3), medium dependency (4-6), y high dependency (7-10)\] |
| Changes in disposition to smoking cessation | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse) |
| Changes in Motivation level | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Richmond's test (\<3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation) |
| Changes in concentration of exhaled CO measured with a CO-oximeter | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | A patient will be considered as an active tobacco user if more than 6 of carboxyhemoglobin particles per million are found through the use of a CO-oximeter |
| Number of patients with surgical complicatoins | Hospitalization period and 90 days after surgical intervention. | Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality |
| Surgery duration | Day of intervention | Time spent in the operation room |
| Need of blood transfusion | Day of intervention | Volume of blood transfused during surgery |
| Hospitalization duration | Days from admitting until discharge. | Number of days of hospitalization after surgery. |
| Need of new hospitalizations | 12 months after surgical intervention. | Number of times patient is admitted to the hospital during follow up |
| Changes in self-efficacy | Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention | Albert Bandura's social cognitive theory |
Countries
Spain
Contacts
Primary ContactEva Gavilán Castillo, RN; MSN
Outcome results
None listed